Adalimumab
- Generic Name
- Adalimumab
- Brand Names
- Amjevita, Cyltezo, Humira, Hyrimoz, Yusimry, Hulio, Hefiya, Libmyris, Imraldi, Amsparity, Idacio, Hukyndra, Amgevita, Yuflyma
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 331731-18-1
- Unique Ingredient Identifier
- FYS6T7F842
- Background
Adalimumab is a subcutaneously administered biological disease modifier for the treatment of rheumatoid arthritis and other chronic debilitating diseases mediated by tumor necrosis factor. It was originally launched by Abbvie in the U.S. and approved in 2002 by the FDA. This drug is frequently known as Humira. It is produced by recombinant DNA technology using a mammalian cell expression system. This drug is available in a prefilled syringe form and convenient pen form for subcutaneous self-administered doses.
Several biosimilars to adalimumab. Adalimumab-atto was the first adalimumab biosimilar approved by the FDA in 2016. Adalimumab-adaz was approved by the FDA on October 31, 2018. Other biosimilars include adalimumab-fkjp, which was approved in July 2022, and adalimumab-bwwd, which was approved in August 2022. A biosimilar marketed as Hyrimoz, a high-concentration formulation of adalimumab, is also available.
- Indication
Adalimumab is indicated for the following conditions:
Adalimumab has also been used off-label to treat Pyoderma gangrenosum.
- Associated Conditions
- Ankylosing Spondylitis (AS), Hidradenitis Suppurativa (HS), Moderate to Severe Chronic Plaque Psoriasis, Moderate to Severe Rheumatoid Arthritis, Moderately to Severely Active Crohn's Disease, Moderately to Severely Active Ulcerative Colitis, Non-infectious Intermediate, Posterior and Panuveitis, Polyarticular Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Pyoderma Gangrenosum
- Associated Therapies
- -
Targeted Ultrasound in Rheumatoid Arthritis
- First Posted Date
- 2014-02-05
- Last Posted Date
- 2019-10-31
- Lead Sponsor
- University of Leeds
- Target Recruit Count
- 183
- Registration Number
- NCT02056184
- Locations
- 🇬🇧
Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom
Bone Resorption, Osteoclastogenesis and Adalimumab
- First Posted Date
- 2014-01-14
- Last Posted Date
- 2018-05-08
- Lead Sponsor
- Université de Sherbrooke
- Target Recruit Count
- 120
- Registration Number
- NCT02035800
- Locations
- 🇨🇦
CRC Étienne Le-Bel at CHUS, Sherbrooke, Quebec, Canada
Adalimumab Intralesional in Intestinal Strictures of Crohn's Disease Patients
- First Posted Date
- 2013-11-18
- Last Posted Date
- 2018-12-13
- Lead Sponsor
- Sara Varea
- Target Recruit Count
- 26
- Registration Number
- NCT01986127
- Locations
- 🇪🇸
Hospital Moises Broggi, Sant Joan Despí, Barcelona, Spain
🇪🇸Complexo Hospitalario Arquitecto Marcide -Novoa Santos, Ferrol, A Coruña, Spain
🇪🇸Complexo Hospitalario Universitario de Santiago, Santiago de Compostela, A Coruña, Spain
Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)
- First Posted Date
- 2013-07-10
- Last Posted Date
- 2015-09-29
- Lead Sponsor
- University Hospital, Tours
- Target Recruit Count
- 110
- Registration Number
- NCT01895764
- Locations
- 🇫🇷
Médecine polyvalente, CH de SAINT NAZAIRE, Saint Nazaire, France
🇫🇷Rhumatologie, CHRU de RENNES, Rennes, France
🇫🇷Rhumatologie, CHD LA ROCHE SUR YON, La Roche Sur Yon, France
Study of Adalimumab to Lower Cardiovascular Risk in RA Patients With Well Controlled Joint Disease
- Conditions
- Interventions
- First Posted Date
- 2013-07-09
- Last Posted Date
- 2021-04-09
- Lead Sponsor
- Jonathan Graf
- Target Recruit Count
- 63
- Registration Number
- NCT01893996
- Locations
- 🇺🇸
University of California San Francisco/San Francisco General Hospital, San Francisco, California, United States
Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study
- Conditions
- Interventions
- First Posted Date
- 2013-06-14
- Last Posted Date
- 2017-07-06
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 422
- Registration Number
- NCT01877668
- Locations
- 🇫🇷
Centre Hospitalier Sud-Francilien - Secretariat de Rhumatologie, Corbeil Essonnes cedex, France
🇺🇸Arthritis Center, Inc., Palm Harbor, Florida, United States
🇨🇿Revmatologie s.r.o., Brno, Czechia
Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)
- Conditions
- Interventions
- First Posted Date
- 2013-06-06
- Last Posted Date
- 2014-09-16
- Lead Sponsor
- Eli Lilly and Company
- Registration Number
- NCT01870284
- Locations
- 🇬🇧
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Leeds, West Yorkshire, United Kingdom
Vascular Inflammation in Psoriasis - Extension Study
- First Posted Date
- 2013-05-31
- Last Posted Date
- 2018-05-22
- Lead Sponsor
- University of Pennsylvania
- Target Recruit Count
- 81
- Registration Number
- NCT01866592
- Locations
- 🇺🇸
Center for Clinical Studies, Houston, Texas, United States
🇺🇸University of California, Davis Health System, Sacramento, California, United States
🇺🇸University of Colorado, Denver, Colorado, United States
Economic Evaluation of Systemic Treatments for Moderate-to-severe Psoriasis
- Conditions
- First Posted Date
- 2013-03-18
- Last Posted Date
- 2017-08-11
- Lead Sponsor
- Jochen Schmitt.
- Target Recruit Count
- 1
- Registration Number
- NCT01812954
Stopping TNF Alpha Inhibitors in Rheumatoid Arthritis
- Conditions
- Interventions
- First Posted Date
- 2013-02-15
- Last Posted Date
- 2024-02-28
- Lead Sponsor
- Georgetown University
- Target Recruit Count
- 290
- Registration Number
- NCT01793519
- Locations
- 🇺🇸
Georgetown University Medical Center, Washington, District of Columbia, United States
🇺🇸National Institutes of Health Clinical Center, Bethesda, Maryland, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.